Nevaniel E. Black, Jr. has over 20 years of experience leading quality assurance and regulatory compliance programs. He has extensive expertise in GMP, GLP, QSR, and ISO operations. Some of his key achievements include establishing quality management systems, conducting internal and external audits, hosting regulatory inspections, and leading validation programs. He is seeking a director or consultant role to manage quality, operational, and technical programs and establish strategic partnerships.

1. Nevaniel E. Black, Jr. Page 1
Nevaniel E. Black, Jr
4200 Maria Lane; Bethlehem, PA 18017
T: 610-691-7094
M: 215-870-0409
E: nevaniel.black@gmail.com
Objective:
Exceptional,knowledgeable andhands-onDirector/SR.Director/Consultantlevel roledriventomanage
quality/operational/laboratory/technical programs,costsandestablishstrategic,mutuallybeneficial
partnershipsandrelationshipswith internal andexternal customersbasedon20+ yearsleadership experience
inGMP, GLP, QSR andISO operations.
Core Achievements:
(Accomplished fromdirect tasks to successfullypromotecompanygoalsandcontinuousimprovement.)
 ExpertinestablishingandmanagingQA andQualityManagementSystemsasa leaderandhands-on.
 Expertininternal andexternal auditing. Prepared/conducted/remediatedPAI andforcause audits.
 Hostedwithsuccess: FDA,HealthCanada, and MHRA, MPA, DEA,USDA, EPA,HomelandSecurity,CDC,
PA DEP and etc. inspections/audits.
 Expertinestablishingrobustdeviation,non-conformanceandCAPA processes,managing, trackingand
drivingtoclosure.
 Expertincreatingthe criteriafor robustchange control processes,managing,trackinganddrivingto
closure.
 Expertand hands-oninasepticfill operations,soliddose filling, IVDmanufacturing,large andsmall
molecule manufacturing, andmedical device manufacturing.
 Expertand hands-oninIQ/OQ/PQ/PV validations withmitigationof anynonconformances(VMP,CVMP,
GAMP, ProductionandLab Equipment, PartsCleaning, Detergents/DisinfectantsandResiduals, Water
Systems, HVAC,AirCompressors,Steam,EO,GammaSterilization, BIIdentificationandQualification, Dry
Heat,ColdRooms,Refrigerators,Freezers, Warehouse Mapping, Incubators,HVAC, Process,ITSystems
and UDI Labelingandetc.)
 Expertincleanroomoperationandmanufacturinginclusive of design,buildoutandqualificationof HVAC
environmental controls,cleaningandmonitoring.
 Expertand hands-oninvalidationof coldchainshippersthroughtrucking/transport.
 Managed andleadlocal,multi-site andglobal projectswithcrossfunctional teamsanddelivered project
successon time.
 Expertinestablishingriskassessmentstodetermineimpacttothe businessandcompliance.
 Established materialmanagementprograms/processesforincomingmaterialsandproducts.
 Expertinlaboratorymanagement,Microbiology,Chemistry,EM,Bioburden,Biocompatibility.
 Trackwise ownerforimplementation,upgradeanddailyuse criteriaforglobal sites.
 Lead Quality Systemprograms forexternal suppliersandcreatedsupplierprograms.
 Managed departmental budgetsforcapital,expensesandheadcount.
 Utilizedeffective writtenandverbal communicationskillstodelivermessaging andforpresentations.
 Lean six sigmacertifiedandmetricdriven.
 Managementanddevelopmentof teammembersandcreatedadulttrainingprogramswithhands-on
training.
 Created,reviewedandapprovedall QualityandTechnical Agreements.
 Developedbusinesscontinuityplans andtrainedonthe execution.

2. Nevaniel E. Black, Jr. Page 2
EmploymentHistory:
Consultant– Validation, Sterilization,QualitySystemProjects Sep 2014 - Present
(formitigationof FDA 483’s andISO auditobservations)
WestChester,PA; Bethlehem,PAand Detroit,MI
Key Achievements:
 Support3 Manufacturingsites(MI,SCand TX).
 Generate validationprotocolsforequipmentandprocessestohelpmitigateFDA 483’s.
 Identifiedrisksandmitigatedeachforsustainablecompliance.
 SME fordevelopingandenhancingthe QualitySystemforaMedical Device QA group.
 Recommendanddevelopmore robustmanufacturingprocessesandidentifycontinuousimprovement
initiatives.
 Create an IT validationprocesstosupportthe business.
 Create a UDI labelingvalidationprotocol tosupportthe new FDA mandate.
 Generate a DesignControl programwithDMR’sand FMEA’s to mitigate FDA 483’s.
 AssistinwritingDesignControl elementstosupportnew medicaldevices.
 Generate laboratoryvalidationprotocolsforinstruments.
 Provide guidance onremediatingqualitysystemgaps.
 SME fordevelopingand enhancingthe QualitySystemforaPharma R&D groupin supportof primary
consultantsfromvirtual locations.
 Reviewedanddraftedresponsestointernal auditobservations,CAPA’sanddeviations.
 Establishedarobustpestcontrol program.
 AssistedinmitigatingaChemical Storage andstorage riskwithinthe R&Dgroup.
 Recommendedbestpracticesforglasswashingactivitiesinclusiveof safety requirements.
 ReviewedQualityAgreements andService LevelAgreements forregulatoryandqualitylanguage.
 DraftedSOP’sandWork Instructions.
 Assistedonateam to write the businesscontinuityplanfortwoR&D sites.
 Recommended specifictrainingforservicegroups.
 Servedasa source forbestpracticesin a 21 CFR 211 R&D environment.
 SME forETO and Gamma sterilizationof medical devices.
 Reviewedandmitigatedexecutedsterilizationvalidationgapsperformedinthe US,France,Switzerland
and Germany.
 Determinedprocessrisksandmitigated.
 ReviewedandmitigatedsterilizationChange Controlsandadoptionsof productfamilies.
 Evaluatedif steamsterilizationcaneffectivelysterilize reusabledevicesbasedondesign.
Quality Packaging SpecialistsInternational,LLC – Macungie,PA Jun 2012 – Dec 2013
Director, Quality Assurance and Compliance
Key Achievements:
 Directed17 QualityAssociates with3DirectReports.
 DevelopedQSinclusive of SOP’sfornewlyconstructedpharmaceutical CMOsite resultingin2 flawless
EIR’s fromFDA. Developedwrittenpolicy“FDA Playbook”withclearexecutionstepsfor all parties.

3. Nevaniel E. Black, Jr. Page 3
Developedthe businesscontinuityplanforthe site withagoal of recoveryof operationsandto support
customerQualityAgreementsandcontracts.
 Createdvalidationprotocolsandexecutedvalidationsandtemperaturemappingof all environmental
chambers/rooms/warehouses.
 Managed the implementationof the DEA programon site. Managementrepresentative withDEA during
the constructionof a newschedule IIvaultandscheduleIII-V cage areawithall of the securityfeatures.
 Createdandmanagedthe CAPA,deviation, OOS, complaint,change control anddocumentationsystems.
ConductedManagementReviewforreportingtoexecutivemanagement.
 OTC productexperienceandassociatedregulatorycompliance experience.
 Resolvedall complex technical issuesrelatedwithcustomerproduct,componentsandprocessesto
preventrejectionsbyusingout-of-the-box thinkingforresolution.
 Oversawandapprovedall computerandutilitysoftware validationsandupgradesinaccordance with21
CFR Part 11 and GAMP 5 practices.
 Understandingandforesightof whatthe customersrequire of aCMO before theypresentoraskto build
strongrelationshipsandbuildconfidence.
 Directedtechnical programsresultinginacceptable equipmentandcleaningvalidations,EMand water
testingdecreasingturnaroundtimesby75% usinginternal resources.
 Workedwith customers and3rd
party laboratoriestocreate all GLP protocolsanddocumentationto
supportchemical, biological testingandvalidations.
 Hostedand directed20+ customerauditsin2 monthperiodwithnocritical observationsforQS.
Interactedandestablishedpartnershipswithall customerQualityliaisons.
 Directedand createdBR templatesforcustomerapproval andreviewedthe executedBR’s.
 Lead developmentof robustQCin-processtestingtomonitoracceptance andfailure modesforsolid
dose,blistering/cartoning,medical device kittingandlabelingof sterileophthalmic vialedproducts.
 AssistedandcreateddocumentationforagencyproductsubmissionswithRA groups.
 CreatedGMP trainingprogramsand trainedall site associates.
FisherClinical Services – Allentown,PA Mar 2009 – Jul 2011
SR. Director/Director, Quality Assurance and Regulatory Compliance
Key Achievements:
 Directed82 QualityAssociatesand9 DirectReports.
 Directedandimprovedall Qualityoperationsinfunctional departments (QA,QS,QE, QC,Validation
Warehouse,Distribution andReturns) inaccordance withGMP,GLP and QSR regulations.
 Servedasthe technical adviserforall projectsrelatedtopackaging,labeling,equipmentvalidation,
testing,biological andchemical requirements/testing,QAA’sandTA’sgenerationandapproval,EM,
required regulatoryfilingdataandcoldchain requirements.
 Directedall asepticfill producthandlingandpreservationof coldchainrequirements.
 Technical adviserforthe selectionandapproval of distributionshippingcontainersandcorresponding
coldpack configurationsforcoldchainandambient,shiptesting,temperaturemonitoring(temptales),
ultra-lowfreezerandrefrigeratorvalidationandtemperaturemappingandin-processlabelingof cold
chainproduct vials.
 Directedthe IQ/OQ/PQvalidationprogramsforequipmentandall individual PQvalidationsforclinical
products.
 Wrote GLP protocolstosupport3rd
party laboratorytestingandwrote andexecutedlaboratory
instrumentationandlaboratoryprocessvalidationsinaccordance withGLP andGAMP 5 guidelines.

4. Nevaniel E. Black, Jr. Page 4
 Developedandwrote the businesscontinuityplanforthe site withafocuson total recoveryof a
packaging/manufacturingsite,tosupportrequiredcustomerQualityandTechnical Agreementsand
compliance toMHRA/MPA. Alsoplannedthe trainingand executionof the plan.
 Directedthe validation,monitoringand maintenance of all laboratories/testingequipment.
 Directedandapprovedall blistermaterialsqualifications(coldformandthermoformedformats)and
ensuringproperregistration of the blistersforblindedstudiescontainingactive,comparatorandplacebo
drugsin the same blisterpack.
 Establishedandvalidatedatestmethodtomonitorforthe absence of oxygenwhenclinical product
packagedundernitrogeninblistersandbottles. Perfectedarobustleakdetectiontestmethodfor
blistersandinductionsealedbottles.
 Collaboratedwithlabel manufacturerforresolutionof technical issuesrelatedtoadhesives,bookletlabel
adhesion/wrinkling/opening,printqualityandpoorvideojetprintingof lotandexpiryontolabels.
 Anticipatedall potentialprocessingissueswithcustomer’sproductsatthe projectphase basedon
previouseventsand understandingof keyattributes. Drove all activitiestomeetdeadlines.
 DirectedandestablishedQC processesforperformingchecksandmonitoringof all distributedclinical
suppliestoclinical sitesaroundthe worldtoensure properpackoutfor temperature requirements,
correctnessof suppliesandproperaddresses.
 Directedandhostedall GMP regulatoryinspections/auditsandpassedall withoutanycritical
deficiencies.
 CreatedandimplementedwithProcurementaSupplierQualityprogramtoensure continuousreceiptof
conformingrawmaterialsandcomponents.
 Establishedanddirectedsiteandglobal QualityKPI’stomonitorQSand usedtodrive continuous
improvementprograms.
 DirectedDEA site program andresponsibleforARCOSandEnd of year reportinganddisposal of drugs.
 Managed site andglobal documentationprogramsandTrackwise. Implementedandinternallyvalidated
the upgradedTrackwise forglobal sitesin3 daysreducingdowntime andmigrationto1weekend.
 Directedandoversawtraining,equipmentvalidation,EH&S,state pharmacylicensingandtechnical
consultingatall NorthAmericansites. OversightforQualityatthe Mount Prospect,ILand Indianapolis,
IN siteswithfrequenttravel toeachsite.
 Lead domesticandglobal projectteamsandalsoleadandservedasa memberonsome customer/Fisher
projectteams.
 Participated andpresented incustomerbusinessQBR’sattheirdomesticandinternational sites.
 Createdandleadthe implementationof adultGMP trainingprogramsfor3 sites.
Organon Pharmaceuticals USA - Allentown,PA Jan 2005 – Mar 2009
Director, Pharmaceutical Packaging Services
Key Achievements:
 Directed80 OPS Associateswith5DirectReports.
 DirectedPackaging, IE, MaterialsManagement,Planning,Receiving,DistributionandSupplyFulfilment
Warehouse operations.
 DirectedandmanagedGLP studieswithR&Dand 3rd
partylaboratoriestosupportRA requirementsfor
newproductlaunches. Wrote,reviewedandapproved protocolsandexecutedvalidations.
 Determinedacceptable limitsforvarioustestsamplesinsupportof validationsandlaboratorytest
results.
 Directedall soliddose,blistering/cartoningandvial labelingprocessesonatightenedscheduleresulting
inthe reductionof FG inventoryfrom6weeksto2 weeks.
 Establishedasepticfill producthandlingandtrainedassociatesinthe process.

5. Nevaniel E. Black, Jr. Page 5
 Directedthe package designsinpreparationforautoloading onequipment. Technical adviserand
approverof all designspecifications,validationandreleasesof new components.
 Createdspecial protocolsfordelabelingprocessesorrelabelingof productwhenexpirydates were
extended.
 Championedthe deploymentof Lean6 Sigmaforthe site anddelivered10+ successful GreenBelt
projectsforprocessimprovements. One projectincreasedthe machine output100% ina shift
eliminatingthe needforhiring20newassociateson secondshift.
 Lead Packagingtoimprove batchrecord RFT passrate to 99.9% anddeviationsto1 permonth.
 Co-hostedFDA andDEA inspectionswithQuality.
 Servedonmultifunctional teamswithall otherdepartmentsinclusive of R&DandAnalytical Laboratories.
 Servedasthe MicrobiologistSMEfor productsubmissionstoregulatoryagencies.
 Launched3 newproductsto the marketand directedthe procurementof the requiredcomponentsand
labelsafterregulatoryapproval.
 Responsible fordepartmental budget,capital andheadcount.
B. Braun Medical,Inc. - Allentown,PA Oct 1995 – Dec 2004
Quality Director
Key Achievements:
 Directed92 QualityAssociateswith12DirectReports.
 Lead all effortstomitigate anyqualityeventsandinteractedwiththe customerSupplyChainQualityand
Technical members.
 Lead andpossessfull understandingof all QualityDepartmentgroupssupportingaCMO Medical Device
Manufacturingsite: QA,QSR/ISOTraining,DocumentControl,BatchRelease,QC-InProcessInspection,
IncomingInspection,Laboratory,Validation,Metrology,Environmental Monitoring,Change Control,
Label Control,Audits(Internal,Customer,Regulatory,Supplier),DrugStability,Non-Conformances,
Complaints,MDR’s,andQE ProcessControl.
 Lead andpossessfull knowledge of Sterilization(EO,GammaandSteam). The Sterilizationunitreported
to me and I approvedall validationprotocolsandreports. Experience inthe ISOdocuments relatedto
EO, Gamma and Steam. Experience withdisinfectantsandcleaningvalidationsfordisposable and
reusable materials. Experiencewithfailedvalidationsorloadsandthe investigations requiredto
mitigate.
 Directedthe constructionof anasepticfill cleanroomandthe validation/qualificationof the processes.
 Builtan internal cell culture laboratorytoperformcytotoxicitytestingtoreduce costsof sendingto3rd
party laboratories. Trainedthe associatesonpropertechnique.
 Directedandperformedlaboratoryrefrigerator,incubatorandoventemperaturemapping validations.
 Directedandprovidedtechnical inputforthe developmentof new products(designcontrol): IV sets,
tubingsets,injectionortransferports/devices,needles,caps,ballooncatheters,syringes,customOEM
deliverydevices,kitsandpackaging materials.
 Lead anddevelopedthe incominginspection,in-processandfinal material/producttestingof raw resin,
raw materials,components,moldedandextrudedpartsforcompliance andreleaseinaccordance with
ISO, GLP, QSR, USP,EP, JP andASTM.
 WorkedwithR&D Engineers,ProcessEngineers,QualityEngineersandValidationEngineerstohelp
designproductsandpackage productsto ensure the abilitytoeffectivelysterilize. Developed
specificationsandIQ/OQandPQ protocolstovalidate equipmentand processes.
 Memberof ContinuousImprovementTeamassignedtoremove waste fromextrusion,molding,“gluing”
and sonicweldingprocessesandestablisha“SmartScope”instrumenttotestmoldedpartsin-process.

6. Nevaniel E. Black, Jr. Page 6
 ManagementRepresentative forISO(TUV) AuditsandFDA QSR Inspections. DirectinteractionwithFDA.
 CreatedtrainingmodulesonQSR,ISO9001, CMDR, GLP, GMP and 21CFR Part 11.
 Directed,establishedandleadthe material biocompatibilityprogramfrommaterial selectionto
laboratorytestingqualificationtoassistnew productdevelopment. Approvedall GLPstudies.
 Managed the biological andanalytical laboratories. Procurednew testequipment,wrote and performed
the final approval of the GLP validationprotocolswithfull understandingof how eachpiece of equipment
operated:plate readers,microIDanalyzers,GC’s,FT-IR,AA,HPLC’s,UV-VIS, Pyrogen-free andDIwater
systems,autoclavesandcleanroommonitoringinstruments.
 Establishedperiodicproficiencytestsforeachof the majorrelease testsforthe analyststoensure
acceptable andsustainable goodtechnique.
 Enrolled the ChemistryLaboratoryinthe accreditedPATprogramtoensure analystswere proficientin
operatinginstrumentation andprovidingacceptable resultsinthe 95% confidence level comparedto
external analyststestingthe same unknownPATsamples.
 Investigatedall OOSresultsinthe laboratoryanddeterminedrootcause.
 Directed,hiredandtrainedassociatesformanufacturingandQCof asepticfill syringesinaclass100
cleanroom.
 Qualityoversightof the BiotechDivisionmanufacturingdialysisinstruments.Qualityoversightof multiple
manufacturingsites:CherryHill,NJ,PuertoRicoandDominicanRepublic. Workedonjointcontinuous
improvementprojects/programswiththe Irvine,CA manufacturingandLaboratorysites.
 Ownerof the departmentheadcount,capital andexpenditure budgets.
 Traveleddomesticandinternational.
J&J(Ortho and RWJ-PRI) – Raritan, NJ
SR. Associate Scientist(Supervisor) –R&D
Diagnon, Corp. – Laurel, MD
SR. Immunologist– R&D
BBL MicrobiologySystems – Baltimore,MD
Immunologist–R&D
MeloyLaboratories (Revlon) – Springfield,VA
QC Laboratory Supervisor- Quality
Education:
Master of Science: Microbiology
Mississippi State University –Mississippi State,MS,USA
Bachelor of Science: Biology
RensselaerPolytechnicInstitute–Troy,New York,USA
References:
Furnisheduponrequest